Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors

Last updated: March 26, 2024
Sponsor: Methodist Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoid Syndrome And Carcinoid Tumours

Abdominal Cancer

Digestive System Neoplasms

Treatment

Peptide Receptor Radionuclide Therapy

Clinical Study ID

NCT04090034
022.HPB.2019.D
  • Ages > 18
  • All Genders

Study Summary

The specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and adverse events associated with PRRT in patients with gastroenteropancreatic primary NETs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. > 18 years of age
  2. Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRTper the treating physician. Specifically:
  • Will consider other primaries on a case by case basis if dotatate scan (+) andmeet all other criteria.
  • Metastatic or Locally Advanced AND Inoperable
  • Clear disease progression on Octreotide over less than 3 years (RECIST 1.1)
  • Presence of disease within 24 weeks as identified by PET/CT scans with Ga-68DOTATATE reporting the Krenning score for low-grade NET and/or PET/CT scans withFDG for transformation to high-grade NET
  • Well differentiated on path - Ki67 < 20%
  • Octreotide positive on pathology (if not documented, acceptable if PET/CT imagingshows lesions with Ga-68 DOTATATE uptakeLabs:
  • Cr. <1.7
  • Hgb >8
  • WBC >2K
  • Plt >75K
  • Bili < 3x normal limit
  • No Octreotide within 30 days of administration.
  1. Willing and able to comply with the protocol requirements
  2. Able to comprehend and sign the Informed Consent Form in English.

Exclusion

Exclusion Criteria:

  • Do not meet the Study Inclusion Criteria laid out in section 6.3

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Peptide Receptor Radionuclide Therapy
Phase:
Study Start date:
March 28, 2024
Estimated Completion Date:
June 28, 2024

Study Description

Neuroendocrine tumors (NETs) make up a large range of malignancies that arise from neuroendocrine cells in multiple organs of the body. Hallet et al conducted a large population-based study that demonstrated that 21% of NET patients presented with metastatic disease and another 38% developed metastases after resection of the primary tumor (Hallet et al., 2015). This burden demonstrates the need for effective systemic therapy for advanced NETs. Options for systemic therapy include peptide receptor radionuclide therapy (PRRT).

A need for more prospective series are needed on treatment responses and survival outcomes related to gastroenteropancreatic primary NETs treated with PRRT was identified. Thus the purpose of this study is to collect clinical data related to treatment of gastroenteropancreatic primary NETs s with PRRT. Clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of gastroenteropancreatic primary NETs with PRRT and on adverse events and complications related to PRRT treatment will be collected.

Connect with a study center

  • Clinical Research Institute at Methodist Health System

    Dallas, Texas 75203
    United States

    Active - Recruiting

  • Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Site Not Available

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